DEVICE: VIA (00816765013694)

Device Identifier (DI) Information

VIA
00717009
Not in Commercial Distribution
00717009
US Endoscopy
00816765013694
GS1
February 03, 2020
1
627879687 *Terms of Use
The VIA Procedure Kit - custom includes basin, transport pads, blue, gauze pads, Biohazard sticker, solidifier, Via enzymatic sponges, lubricating jelly, Double-Header cleaning brushes, brush, and BioShield biopsy valves.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61950 Endoscopy preparation kit
A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NWU Endoscope introducer kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

b83de7c5-38df-49de-b24c-effa0af8732c
February 03, 2020
5
June 30, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10816765013691 18 00816765013694 2020-02-03 Not in Commercial Distribution Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)548-4873
xx@xx.xx
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